Drug factory · FDA FEI 3002807530
Macfarlan Smith Limited
10 Wheatfield Road, Edinburgh, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Nov 29, 2021.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2012: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Apomorphine | Makes the active ingredient | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc., TruPharma LLC. | 27505-004, 52817-720 |
| Buprenorphine | Makes the active ingredient | Hospira, Inc. | 0409-2012 |
| Buprenorphine and Naloxone | Makes the active ingredient | Indivior Inc. | 12496-1202, 12496-1204, 12496-1208 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 29, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 10, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 4, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 13, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.